Tag Archives: Levaquin

Janssen Pharmaceuticals, part of Johnson & Johnson, has stopped production of (brand-name) Levaquin, according to the article, “Drug maker stopped making popular antibiotic Levaquin amid concerns about mental health side effects” published on the Indianapolis ABC affiliate RTV6 The Indy Channel. Janssen/J&J stopped producing both oral and IV Levaquin in December, 2017. The discontinuation of Levaquin production was confirmed by a Janssen/J&J spokesperson who stated, “The decision to discontinue LEVAQUIN was made due to the wide availability of alternative treatment options, and our focus on developing innovative medicines designed to address unmet medical patient needs.” Though that statement is BS propaganda, it is a direct confirmation from a Janssen Pharmaceuticals spokesperson that JANSSEN/JOHNSON & JOHNSON HAS DISCONTINUED PRODUCTION OF LEVAQUIN.

THIS IS REALLY BIG NEWS! IT’S HUGE! WHOA!

LEVAQUIN HAS BEEN REMOVED FROM THE MARKET!

Unfortunately, there is still plenty of levofloxacin (generic Levaquin, made by hundreds or thousands of generic pharmaceutical producers) on the market, and it is maiming (and killing) thousands of people each year. The fight against these drugs is far from over.

Still, the removal of brand-name LEVAQUIN from the market is a really big deal, and it’s something that we, as a community, should celebrate.

“Never doubt that a small group of committed people can change the world. Indeed it is the only thing that ever has.”—Margaret Mead

I never thought that one of the pharmaceutical giants that has made billions from fluroquinolones would stop making them. Janssen Pharmaceuticals and J&J are huge–they are behemoths–and I never thought that we could move or effect them. But we did.

The efforts of everyone in the “floxie” community contributed to this outcome. We–you–should be proud.

That is my optimistic take on things. We all have an optimistic side. We all have a pessimistic side too, and here’s the bad news.

Victims of pharmaceuticals can’t sue drug-makers for harming them, they can only sue for “failure to warn” of the dangers of the drugs. This is ridiculous – I can sue you for hitting me in the face with a sledgehammer even if you warn me that you’re going to do it and that it’s going to hurt – but pharmaceutical companies aren’t held to the same standards as you or me. It’s assumed that their deadly products are mainly good and that warning of the potential for bad effects is sufficient to wash their hands of liability and responsibility. On top of that, they don’t even have to directly warn YOU, they only have to say that they warned your doctor, the “learned intermediary” of the dangers of the drugs (or, at least they have to in theory – it’s assumed that doctors actually know what’s on the warning labels for pharmaceuticals… but most don’t). Both the “failure to warn” notion and the “learned intermediary” notions are crap, and I hate them, but they’re how the system is set up.

In July, 2008, fluoroquinolone warning labels were changed to note that, “FDA is notifying the makers of fluoroquinolone antimicrobial drugs for systemic use of the need to add a boxed warning to the prescribing information about the increased risk of developing tendinitis and tendon rupture in patients taking fluoroquinolones and to develop a Medication Guide for patients.” – Drug Safety Communication

With each of these warning label changes, the door opened for people to sue Janssen and Johnson & Johnson for the harm that Levaquin did to them. (It should be noted that each of these warning labels changed because of advocacy done by the “floxie” community. We screamed, and, slowly, the FDA listened.) Some people did successfully sue the drug companies that hurt them–they gained some compensation and justice.

Perhaps it’s cynical, but it certainly seems more logical than the BS explanation the Janssen spokesperson gave (noted above) that the reason that Janssen Pharmaceuticals took Levaquin off the market was because they didn’t want to be held liable for the blood sugar level changes and the mental health side-effects of Levaquin. They weren’t making much money off it anyhow (because of generics taking the bulk of the market share), this warning label update opened up a new load of liability, and they did a cost-benefit analysis that led them to take it off the market.

All’s well that ends well, and they took Levaquin off the market, and that’s a good thing, right? Well, it’s more complicated than that.

Because of a stupid and asinine rule put in place by the FDA and a lousy decision of the Supreme Court, victims of generic pharmaceuticals cannot sue generic pharmaceutical manufacturers. It all goes back to the “failure to warn” rules noted above. The FDA says that only brand-name drug manufacturers can change drug warning labels, and since generic drug manufacturers can’t change the warning labels, they cannot be held responsible for what’s on the warning labels. This results in victims of generic drugs being unable to hold anyone responsible for the harm done to them by the drugs. There have been a couple cases where brand-name drug companies were held responsible for the harm done by generic drugs, but the precedent wasn’t set very solidly, and most attorneys in most states still aren’t taking cases of people who have been hurt by generic pharmaceuticals. Still, I think that Janssen and J&J saw the writing on the wall–that they could potentially be held responsible for all the Levaquin and levofloxacin-induced mental health side effects, permanently disabling side effects, permanent peripheral neuropathy, tendon tears, and more. So, they hedged their bets. Their legal team, I’m betting, will now argue that they can’t be held responsible for the harm done by levofloxacin because they don’t even make Levaquin any more, and how can they be held responsible for a product that they don’t even produce? My reply is that they can, and should, be held responsible for the drug that THEY CREATED. Johnson & Johnson created and held the patent on Levaquin for a long time. They made billions of dollars off of it. They can, and should, be held responsible for the effects of their creation. The generic drug companies should also be held responsible for the harm that their drugs do, and the FDA should be held responsible for their warning labels (and failure to warn the public about these incredibly dangerous drugs).

We should also be diligent about the consequences of the removal of Levaquin from the market, and we should continue to work for change in the legal/justice system so that it leans more toward justice for victims, and less toward corporate protection. It is horridly difficult for victims of pharmaceuticals to gain justice or compensation through the legal system as it is currently set up. Janssen pharmaceuticals just made a move to make it even more difficult for victims of Levaquin and levofloxacin to gain justice.

Know what they’re doing. Stay on top of them. Celebrate our victories, then come back to the battlefield fighting. As long as millions of prescriptions of levofloxacin are distributed each year, and thousands of people are maimed by the drugs, our fight isn’t over.

Additionally, it is known that fluoroquinolones cause neurological problems, and can lead to painful and debilitating peripheral neuropathy. (In 2013, fluoroquinolone warning labels were updated to note that Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, and Floxin/ofloxacin can cause permanent and disabling peripheral neuropathy.)

“The results of our study are consistent with an increase in the risk of CTS with FQs. The risk was consistent among all risk periods with a slight increase among past users, which may be due to the longer period elapsed for CTS to manifest itself. FQ-related neurotoxicity can persist cumulatively in relation to exposure levels [8, 9]. The exact mechanism by which this occurs is unknown [9], but proposed models include direct nerve inflammation and ischemia from toxic metabolite and free radical formation [10], and FQ-induced tendonitis/tendinopathy causing mechanical compression upon the adjacent nerves (eg, median nerve) that share the carpal tunnel [11]. Reports of nerve biopsy studies on patients who have experienced FQ adverse events have revealed significantly reduced nerve fiber density consistent with small fiber neuropathy, which may be a potential mechanism of CTS [12]. Although neurotoxicity is the second most commonly reported adverse event, with several studies documenting FQ association with central and peripheral nerve damage [8, 9], this is the first large-scale study exploring the relationship between FQs and CTS.”

“CTS is a disease of significant societal burden with a prevalence of 5% and incidence of up to 2.3 per 1000 person-years [4, 5]. CTS causes loss of function and decreased quality of life for individual patients, and also comprises a large cumulative drain on healthcare and socioeconomic resources from loss of productivity and worker’s compensation claims [6]. One study of 4443 CTS claimants in Washington State estimated a cumulative socioeconomic cost of US$197–$382 million over 6 years for this cohort alone [6].”

Fluoroquinolones are increasing the risk of CTS in millions of people (20+ million prescriptions for fluoroquinolones are written each year). Are doctors or patients aware that they are increasing the patient’s chances of CTS–a painful, debilitating, and costly condition–when fluoroquinolone antibiotics are taken? I doubt it, but they should be.

PJ was given IV levofloxacin/levaquin and flagyl in the hospital, and afterward he suffered from multiple severe side-effects including debilitating fatigue, peripheral neuropathy, body-wide numbness, pain, inflammation in all his joints, and more.

He has come a long way, and he is 80% recovered.

PJ is wonderfully insightful and inspirational. Please listen to, review, and share, this episode of The Floxie Hope Podcast. Thanks!!

Tara has noted several times that she was not as far along in her journey as she thought she was when she wrote her story. Please listen to the podcast for more information about Tara’s journey. It is not a repeat of her story above.

Tara gives a wealth of information about her journey, and how complete avoidance of fluoride, along with various homeopathic methods, supplements, and other things, have helped her through the last two years.

Also, here are some notes and resources from Tara to accompany the information she gives in the podcast:

“What I’m told by fluoride experts is that it matters how much fluoride was already accumulated in your system if you get fluoride poisoned or if you are already sensitive to it by genetics or be because of other chemicals or stressors. Also, whether or not a person becomes hypersensitive does not seem to correlate with how badly they are injured. Ex: People who are hurt much worse than me, still may not become hypersensitive. The spectrum of sensitivity may not have anything to do with the amount of injury from what I can tell through research or peoples’ stories.”

“Also, Im not sure if I was clear about the Fluoride Poisoning symptoms – a person does not usually “feel” anything after ingesting fluoride or coming in contact with fluoride – only a hypersensitive person like myself, which is rare -most people who are poisoned because of fluoride just develop symptoms/diseases/disorders due to the enzymes, tissues, and structures that are poisoned. Most people discover they are poisoned from fluoride by getting completely off of it and symptoms get better (damage has to be repaired over time, some damage is not repairable for all people – but there is always hope of better).”

“Coffee – I forgot to mention this most important topic! 🙂 I was not able to drink anything caffeinated – not even a sip – for 20 months – using the SCIO to heal neurotransmitters (Adenosine is neurotransmitter associated with caffeine receptor site – also used SCIO to heal neurotransmitters in general helped immensely, to heal nerves, healing mitochondria DNA, food allergies, and attempting to desensitize from fluoride).

I am more than happy to report I can now drink a small cup of Bulletproof coffee (free of mold), and put Brain Octane (distilled coconut oil – helps mitochondria for brain energy), butter (also good for brain), and when my fluoride is low enough, I can handle also putting in the Collagelatin powder in the coffee (good way to replace collagen and gelatin) for me. This is all mixed in a food processor together to combine – according to his book, there is a scientific reason why stirring doesn’t have same effects so needs to be blended. I really like the taste and that it’s mold free. The founder of Bulletproof used to have Chronic Fatigue Syndrome, mold allergies, I think also Lyme, etc – so his story is good to read for inspiration – it brought him to a lot of research on mitochondria and health and building this very successful company.
bulletproof.com
(This is also the coffee I use for coffee enemas – it does matter that the coffee is pesticide and toxin free as possible – helped with small intestinal bacteria overgrowth SIBO)”

Allerphase (allergy/asthma herbal supplement – https://www.tangoherbs.com/allerphase60.html (side note: My son, 10-years-old, was able to get off his allergy and asthma medications – he has been on them since age 3, with the addition of Allerphase and MSM (from mercola.com), as well as getting off dairy/gluten and switching to an organic diet)

Harmless Harvest Coconut Water from Whole Foods (all coconut water is not made equal – some are highly processed – good idea to do some research – this is the one I use)

Hyperbaric Oxygen Chamber Treatment – http://www.oxygenunderpressure.com/ – This is the HBOT Institute I went to – it’s a stand alone chamber by the Kansas City, MO airport – people from all over the United States come here for treatment – sessions were $125-$175 per session, 40 sessions is what was recommended. Expensive but worth getting my brain back.

Magnesium – fluoride chelates this mineral as well (FTRC said Kal brand – found at whole foods is good). I use Epsom Salt. If I wasn’t as sensitive to fluoride, I would choose Ancient Minerals magnesium lotion – loved it.

This article was sent to me by my chiropractor- it’s is by Dr. Jack Kruse – about being floxed and what to do about it – good information on staying away from EMFs, fluoride, etc. (I am very sensitive to EMFs since being floxed/fluoride poisoned)

There are a couple of new books available on Amazon about dealing with, and making it through, fluoroquinolone toxicity. Both of the following books are written by “floxed” women, and both generously share a message of hope, perseverance, and strength through the difficult and painful journey of fluoroquinolone toxicity.

Praying Through Pliés: Living With Lupus and Surviving An Antibiotic Called Levaquin

“A nurse’s true and inspiring journey of living with lupus and later surviving a devastating reaction to the fluoroquinolone antibiotic, Levaquin, by weaving her faith and her love for ballet into a powerful story of transformation. Beautifully and poignantly written, the author addresses her personal loss, grief, sadness, and anger, but the prevailing message is one of hope, love, and gratitude. Included are sections on exercise, sleep, stress management, and nutrition with simple and realistic suggestions for change. This book has the potential to bring healing, hope, and joy to those dealing with chronic illness, loss, or challenges of any kind, but it is also is for anyone who desires to make positive changes in his or her life. Also written for those who suffer from adverse reactions to fluoroquinolone antibiotics and who are unheard or even discounted, this story provides support and encouragement, while adding one more voice of credibility to their pain and disabilities.”

In an email correspondence, Jean also noted that, “Early readers have said it is a powerful and inspiring story of healing and transformation. I combine faith and my love for ballet to offer others what I have learned about lifestyle changes in the areas of stress management, nutrition, sleep, stress management, and exercise, the importance of positive thinking, and the power of gratitude. My hope is that this book will bring hope and healing to others.”

Thank you so much for writing about your journey through fluoroquinolone toxicity (on top of autoimmune diseases) and for sharing it with the “floxies” of the world, Jean!

“When I was growing up, I pictured myself as a nurse, an olympian, an astronaut…but never handicapped. I just didn’t see that coming. I was as happy and enthusiastic to greet this new challenge, as I would be a swarm of bees. It can be very hard to accept great trial with open arms.
I might be lame, but my story isn’t. Nearly seven years ago at the age of 28, my body suddenly disintegrated underneath me. My doctors had no idea why my previously healthy body was imploding. I was a spunky young wife and mother stunned by her new circumstances. Discovering the cause offered no cure. What now? Where do I go from here?
When I’m overwhelmed by this burden, and I’m too heavy to forge ahead, the hand of God lifts me and leads me on. My journey is incredibly hard, but immeasurably blessed by God. Impossible situations give God opportunity to shine and us an opportunity to trust. Miracles wouldn’t be miracles if they were possible. You know the phrase, “When life gives you lemons…make lemonade.” I’ll give you a new one. When life throws you dung, use it as fertilizer to grow your mustard seed of faith. It may move a mountain or grant you the strength to traverse over it.
This story is about building an unconditional faith in God even during the most grueling moments of my life. I’m finding beauty and hope along a rugged path I never would have chosen for myself.”

An Amazon review of the book, from Roland, stated:

“Amy Moser has endured more pain and suffering than anyone should ever have and all because of one medication for a mild infection. Her heart for God and her iron clad faith in His goodness and mercy have kept her going for her devoted husband and her children. I have never read a stronger testimony about the power of prayer and an unwavering faith. This is a very important book because of the warning about Cipro and the other drugs in its category and how catastrophic the side effects can be. But more importantly, seeing her faith as she describes dealing with the truly awful things happening to her formerly healthy body is a gift to us all. Read this book. Learn more about the side effects of these dangerous drugs. They are horrifying. Then say a prayer for Amy Moser and all the others suffering because of these drugs.”

Both books are generously and thoughtfully written. They describe journeys of hope and faith, and they are gifts to those who read them. I hope that they help you through your journey through fluoroquinolone toxicity as well!

It is well known that fluoroquinolone antibiotics (Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, Floxin/ofloxacin, and a few others) damage connective tissues–including musculoskeletal connective tissues like tendons, cartilage, bone, and muscle, as well as other connective tissues such as ocular tissue (including the retina), eardrums, and cardiac/heart tissue. Multiple studies have found that fluoroquinolones are toxic and damaging to connective tissues. Given the wide differences in tissues that fluoroquinolones have been shown to deleteriously affect–from cartilage to cardiac/heart tissue–it is reasonable to assert that they damage all connective tissues throughout the body. (Read any of the articles in the citations listed below for information about how fluoroquinolones damage connective tissues.)

Given that fluoroquinolones damage connective tissues (probably all connective tissues), I have a new, developing, hypothesis for how fluoroquinolones lead to fluoroquinolone toxicity syndrome/fluoroquinolone associated disability (FQAD). Please keep in mind that this is one of many hypotheses, and it is just one among about a dozen possibilities (you can read about some of the other possibilities on the post What is Fluoroquinolone Toxicity, or through the free ebook Hacking Fluoroquinolones.)

Hypothesis:

Fluoroquinolones damage the dura (dura mater)–the layer of connective tissue that surrounds the brain and spinal cord and keeps spinal fluid around those vital organs. This leads to spinal fluid leakage, which leads to many symptoms of fluoroquinolone toxicity, including:

This wonderful lecture by Dr. Ian Carroll describes how cerebrospinal fluid leaks can lead to symptoms of many illnesses, including “mysterious” diseases like POTS, ME/CFS, fibromyalgia, as well as heart palpitations and severe headaches.

I suggest that you watch the entire video, as well as Dr. Carroll’s other videos on youtube. Here are some notes/highlights from the video above:

Many symptoms of POTS are actually cerebrospinal fluid leaks

The spinal cord is surrounded by tissue called the dura, and the dura holds cerebrospinal fluid around the spinal cord and brain. It’s like a water-tight bag that holds in cerebrospinal fluid and maintains pressure.

There are people out there who have cerebrospinal fluid leaks that aren’t being recognized. Many people with cerebrospinal fluid leaks are misdiagnosed. Cerebrospinal fluid leaks are fixable and it is a shame that they aren’t all being recognized.

The connection between the pituitary gland and the brain can be disturbed, and this can lead to hormonal disruptions. High prolactin is an indicator of this problem.

Cerebrospinal fluid leaks can cause sagging of other parts of the brain.

MRIs of people suffering from cerebrospinal fluid leaks often appear normal. They are subtle and most doctors aren’t trained to see them.

Treatment of cerebrospinal fluid leaks

Epidural blood patches (Dr. Carroll describes how they’re done)

Cerebrospinal fluid leaks are NOT RARE, they’re just misdiagnosed and under-recognized

Before I watched Dr. Carroll’s lecture, I knew that cerebrospinal fluid leaks were painful and debilitating, but I didn’t realize that they were connected to “mysterious” disease symptoms or autonomic nervous system damage.

Connecting cerebrospinal fluid leaks to fatigue, a racing heart, blood pressure and blood sugar irregularities, tinnitus, cognitive and memory problems, hormonal abnormalities, etc. establishes a plausible connection between the (well-established) connective tissue damage done by fluoroquinolones, and the array of chronic, mysterious, disease symptoms that people with fluoroquinolone toxicity suffer from. Perhaps fluoroquinolones cause an array of debilitating chronic, mysterious illness symptoms through damaging the dura and allowing cerebrospinal fluid to leak–which leads to multiple symptoms of fluoroquinolone toxicity (and other chronic illnesses). It certainly seems like a plausible hypothesis to me. It actually seems like an easier hypothesis to postulate and prove than many of the other hypotheses regarding fluoroquinolone toxicity that have been put forth. As I noted above, the damage that fluoroquinolones do to connective tissues is well-established and recognized, and if someone looked at the effects of fluoroquinolones on dura mater tissue specifically, this hypothesis would be easily testable.

Some additional evidence supporting the possible connection between fluoroquinolones and cerebrospinal fluid leaks comes from the large number of people in cerebrospinal fluid leak support groups that have taken fluoroquinolones in the past who assert that fluoroquinolones contributed to their cerebrospinal fluid leak. I know that asking people in facebook support groups doesn’t count as a scientific study, but (to the best of my knowledge) no scientific studies of the link between fluoroquinolone use and cerebrospinal fluid leaks has been done, and the testimonials of the people who have cerebrospinal fluid leaks are important–they point both researchers and fellow patients toward research that may provide answers.

I also find it to be interesting that cerebrospinal fluid leaks affect the pituitary gland, which affects hormone production and regulation. Many people with fluoroquinolone toxicity syndrome have hormonal problems–from tanked testosterone to thyroid abnormalities. Maybe fluoroquinolones cause damaged dura tissue, which causes cerebrospinal fluid leaks, which causes pituitary gland structural abnormalities, which causes hormonal dysregulation, which causes multi-symptom chronic illness symptoms.

Dr. Carroll’s hypotheses and observations are fascinating and exciting for those who are dealing with fluoroquinolone toxicity and other multi-symptom, chronic, mysterious illnesses. I hope that they are explored further. Dr. Carroll’s results with patients are incredibly promising, exciting, and hopeful for people who are suffering from multi-symptom, chronic, mysterious illnesses–including those suffering from fluoroquinolone toxicity. I hope that Dr. Carroll, or other clinicians or researchers, look into the connections between fluoroquinolones and chronic cerebrospinal fluid leaks. It’s possible that the connections could lead to a comprehensive theory of fluoroquinolone toxicity, and may also lead to breakthroughs in other chronic illnesses.

Consumer Reports has published several articles about the dangers of fluoroquinolone antibiotics (including Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, Floxin/ofloxacin, and a few others). Their help in getting the word out to their readers about the risks associated with fluoroquinolone antibiotics is greatly appreciated!

The picture above, from the August, 2016 print issue of Consumer Reports, states:

These potent antibiotics are often prescribed to treat bronchitis, sinus infections, and urinary tract infections. But drugs such as ciprofloxacin (Cipro), levofloxacin (Levaquin), and ofloxacin (Floxin) can cause irregular heartbeats, depression, nerve damage, ruptured tendons, seizures, and other serious side effects. The Food and Drug Administration issued an alert in May saying that fluoroquinolones should not be used to treat bronchitis, sinus infections, and UTIs, unless other options have not worked.

Avoid Problems. If your doctor suggests a fluoroquinolone, ask why. For sinus infections, you might need an antibiotic if your symptoms last more than a week or if you have a high fever, but the first option should be amoxicillin. For a UTI, fluoroquinolones are only necessary if the infection is resistant to other antibiotics or has spread to your kidneys. And they are necessary for chronic bronchitis only if you require hospitalization.

“For example, fluoroquinolone antibiotics such as ciprofloxacin (Cipro and generic) and levofloxacin (Levaquin and generic)—which are frequently prescribed inappropriately for sinus infections in adults—can cause permanent and debilitating damage to muscles, tendons, and nerves.”

As the title of the article says, there are safer, better options than fluoroquinolones (in many situations).

“Research published in The Lancet, a British medical journal, shows that when doctors in U.K. hospitals cut back on prescribing Cipro, Levaquin, and other so-called fluoroquinolone antibiotics, the rate of deadly infections from the bacteria known as C. diff dropped a whopping 80 percent.”

Fluoroquinolones wipe out the good bacteria that keep c. diff bacteria suppressed. When those good bacteria are eliminated, c. diff infections can take over. C. diff infections can be deadly, and all healthcare professionals should take note of this (somewhat counterintuitive) study.

All of the articles linked to above also note that fluoroquinolone over-use is contributing to antibiotic resistance.

All of these Consumer Reports articles are greatly appreciated, and I encourage you to read them, comment on them (where possible), and share them with your loved ones.

Consumer Reports has been a trusted source of information, and a strong advocate for consumer protection, since its founding in 1936. The articles linked-to above are from a highly respected source that is trusted by millions of people. It is a credible publication.

For a trusted and credible publication like Consumer Reports to be publishing information about the severe and varied health maladies that are associated with flouroquinolones is a huge step in the right direction. Their acknowledgement of the FDA’s updated warnings on fluoroquinolones, as well as the testimony of patients who have been hurt by fluoroquinolones, is appreciated immensely.